BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9383395 · Received November 27, 2019

    Report

    Report Number
    3005075853-2019-23834
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    January 1, 2013
    Report Date
    October 29, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DATE OF EVENT: PUBLICATION YEAR OF 2013. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. (B)(4).

    Description of Event or Problem · 1

    TITLE: USEFULNESS OF VESSEL-SEALING DEVICES COMBINED WITH CRUSH CLAMPING METHOD FOR HEPATECTOMY: A RETROSPECTIVE COHORT STUDY AUTHORS: ATSUSHI NANASHIMA, TAKAFUMI ABO, JUNICHI ARAI, KATSUNORI TAKAGI, HIROFUMI MATSUMOTO, HIROAKI TAKESHITA, TOMOSHI TSUCHIYA, TAKESHI NAGAYASU CITATION: INTERNATIONAL JOURNAL OF SURGERY 11 (2013) 891-897. DOI: HTTP://DX.DOI.ORG/10.1016/J.IJSU.2013.07.012. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE EFFICACY OF THE VESSEL-SEALING DEVICES FOR CONTROLLING BLOOD LOSS, TRANSECTION TIME AND POSTOPERATIVE COMPLICATIONS IN HEPATECTOMY AS A COHORT STUDY. THIS RETROSPECTIVE STUDY INVOLVES 267 PATIENTS WITH LIVER DISEASE WHO UNDERWENT HEPATIC RESECTION BETWEEN 2005 AND SEPTEMBER 2012. ONE HUNDRED EIGHTEEN PATIENTS UNDERWENT THE CONVENTIONAL CRUSH CLAMPING METHOD BETWEEN 2004 AND 2008 (CONTROL GROUP) AND 149 PATIENTS USED VESSEL SEALING DEVICES BETWEEN 2008 AND 2012 (VS GROUP). OF THE 149 PATIENTS IN THE VS GROUP, 120 PATIENTS (80 MALE AND 40 FEMALE) USED LIGASURE DEVICES AND 29 PATIENTS (20 MALE AND 9 FEMALE) USED HARMONIC FOCUS (ETHICON)(N-24; 15 MALE AND 9 FEMALE) OR HARMONIC ACE(ETHICON) (N-5; 5 MALE; MEAN AGE 58±9 YEARS). IN THE CASE OF OPEN LAPAROTOMY, LARGER VESSELS WERE TIED USING ABSORBABLE BRAID (ETHICON). GLISSONIAN BRANCHES NEAR THE SECONDARY TRUNK WERE ALSO TIED. THE ISOLATED LARGE HEPATIC VEIN WAS LIGATED BY ENDOPATH-ENDOCUTTER ETS-FREX 35 (STAPLE LOAD; 3.0X35 MM, WHITE CARTILAGE; ETHICON). THE HARMONIC FOCUS CURVED SHEARS (ULTRASONIC COAGULATOR DISSECTOR; ETHICON) WAS USED FOR OPEN LAPAROTOMY AND IN LIMITED RESECTION, SEGMENTECTOMY OR SECTIONECTOMY AND IN HEMIHEPATECTOMY OR MORE EXTENDED HEPATECTOMY. A HARMONIC DEVICE GENERATOR 300 SYSTEM (ETHICON) WAS OPERATED USING A HAND SWITCH (ETHICON), AS A FULL FEATURED HIGH-FREQUENCY MECHANICAL ENERGY SYSTEM. ANY BLEEDING SITE AND MACROSCOPICALLY DETECTED BILE LEAKAGE POINTS IN THE CUT PLANE WERE SUTURED USING ABSORBABLE 4-0 MONOFILAMENT POLYDIOXANONE (PDS)-II SUTURE (ETHICON). REPORTED COMPLICATIONS IN THE LIGASURE GROUP DURING LIMITED RESECTION, SEGMENTECTOMY OR SECTIONECTOMY INCLUDED BLOOD LOSS (703±619/560±474) (N-?) IN WHICH 5 PATIENTS RECEIVED RED CELL TRANSFUSION, HEPATECTOMY-RELATED COMPLICATIONS ¿ (N-?), BILE LEAKAGE (N-1) WHICH WAS SUTURED USING ABSORBABLE 4-0 MONOFILAMENT POLYDIOXANONE SUTURE, AND INTRAABDOMINAL ABSCESS FORMATION (N-2) REPORTED COMPLICATIONS IN THE LIGASURE GROUP DURING HEMIHEPATECTOMY OR MORE EXTENDED HEPATECTOMY INCLUDED BLOOD LOSS (1029±637/952±567) (N-?) IN WHICH 11 PATIENTS RECEIVED RED CELL TRANSFUSION, HEPATECTOMY-RELATED COMPLICATIONS ¿ (N-?), BILE LEAKAGE (N-2) WHICH WAS SUTURED USING ABSORBABLE 4-0 MONOFILAMENT POLYDIOXANONE SUTURE, AND INTRAABDOMINAL ABSCESS FORMATION (N-3). REPORTED COMPLICATIONS IN THE HARMONIC GROUP DURING LIMITED RESECTION, SEGMENTECTOMY OR SECTIONECTOMY INCLUDED BLOOD LOSS (534±445) (N-?), BILE LEAKAGE (N-1) WHICH WAS SUTURED USING ABSORBABLE 4-0 MONOFILAMENT POLYDIOXANONE SUTURE. REPORTED COMPLICATIONS IN THE HARMONIC GROUP DURING HEMIHEPATECTOMY OR MORE EXTENDED HEPATECTOMY INCLUDED BLOOD LOSS (1410±1010) (N-?) IN WHICH 4 PATIENTS RECEIVED RED CELL TRANSFUSION HEPATECTOMY-RELATED COMPLICATIONS ¿ (N-?), UNCONTROLLED ASCITES (N-8), BILE LEAKAGE (N-4) WHICH WAS SUTURED USING ABSORBABLE 4-0 MONOFILAMENT POLYDIOXANONE SUTURE, AND INTRAABDOMINAL ABSCESS FORMATION (N-3). IN CONCLUSION, THE LATEST VESSEL SEALER IS VERY USEFUL FOR OPEN AND LAPAROSCOPIC HEPATECTOMY FOR HEPATIC PARENCHYMAL TRANSECTION IN COMPARISON WITH THE CONVENTIONAL PROCEDURE, DUE TO THE MINIMIZATION OF BLOOD LOSS AND THE SHORTENING OF TRANSECTION TIME, RESULTING IN BETTER POSTOPERATIVE OUTCOMES IN HEPATECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177754 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention